[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-klarity-kratom-634501-06302022":3,"fda-latest-sync-dates":29},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":8,"case_status":13,"letter_url":14,"reference_number":8,"marcs_cms_no":15,"product_type":16,"delivery_method":17,"recipient_name":8,"recipient_title":8,"body_html":18,"body_text":19,"body_fetched_at":20,"medical_device_id":8,"raw":21,"created_at":27,"updated_at":28},2595,"klarity-kratom-634501-06302022","Warning Letter","Klarity Kratom",null,"Center for Drug Evaluation and Research | CDER","Finished Pharmaceuticals\u002FUnapproved New Drug","2022-07-05","2022-06-30","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fklarity-kratom-634501-06302022","634501","Drugs","Via Email","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n              \u003Cdt class=\"cell-1_1\">Delivery Method:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_1\">Via Email\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Drugs                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\u003C\u002Fdd>\n                    \n            \u003Cdd>Klarity Kratom\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">2641 S. Hill St.\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Los Angeles\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">CA\u003C\u002Fspan> \u003Cspan class=\"postal-code\">90007\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\u003C!-- Loop this field. For FDA Office content type. Display the Other contact channel is a dd span with an icon-->\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:klaritykratom@gmail.com\"> klaritykratom@gmail.com\u003C\u002Fa>\u003C\u002Fdd>\n    \u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:klaritykratom3@gmail.com\"> klaritykratom3@gmail.com\u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Center for Drug Evaluation and Research | CDER\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n         \n          \u003Cdd>\u003C!-- Loop this field. For FDA Office content type. Display the Other contact channel is a dd span with an icon-->\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan class=\"fa fa-address-card\" aria-hidden=\"true\">\u003C\u002Fspan> Federal Trade Commission\u003C\u002Fdd>\n\n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp class=\"MsoHeader text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp class=\"MsoHeader\">June 30, 2022\u003C\u002Fp>\n\n\u003Cp class=\"MsoHeader text-align-center\">RE: 634501\u003C\u002Fp>\n\n\u003Cp class=\"MsoHeader\">Dear Klarity Kratom:\u003C\u002Fp>\n\n\u003Cp class=\"MsoHeader\">This letter is to advise you that the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) reviewed your website at https:\u002F\u002Fklaritykratom.com\u002F on May 31, 2022 and in June 2022, respectively, and have determined that you take orders there for numerous kratom products. The claims on your website establish that your kratom products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act.\u003C\u002Fp>\n\n\u003Cp class=\"MsoHeader\">The Department of Health and Human Services (HHS) has determined that a public health emergency exists nationwide involving the opioid crisis.\u003Csup>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup> You market kratom products for the treatment or cure of opioid addiction and withdrawal symptoms. However, these products have not been determined by FDA to be safe and effective for these (or any other) uses. Further, the unproven treatments could cause patients to forego or delay FDA-approved treatments for opioid addiction or withdrawal. The marketing and sale of unapproved opioid addiction treatment products is a potentially significant threat to the public health. Therefore, FDA is taking measures to protect consumers from products that, without approval by FDA, claim to diagnose, mitigate, prevent, treat or cure opioid addiction.\u003C\u002Fp>\n\n\u003Cp class=\"MsoHeader\">\u003Cstrong>Unapproved New Drugs\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp class=\"MsoHeader\">Your kratom products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and\u002For intended to affect the structure or any function of the body.\u003C\u002Fp>\n\n\u003Cp class=\"MsoHeader\">Examples of claims observed on your website, https:\u002F\u002Fklaritykratom.com\u002F, that establish the intended use of your products as drugs include, but may not be limited to, the following:\u003C\u002Fp>\n\n\u003Cp class=\"MsoHeader\">On your webpage https:\u002F\u002Fklaritykratom.com\u002F2018\u002F09\u002F20\u002Fkratom-an-introduction\u002F:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli class=\"MsoHeader\">“[O]ver ninety percent of patients suffering from rheumatoid arthritis . . . have reported partial or total improvement in their symptoms after using Kratom.”\u003C\u002Fli>\n\t\u003Cli class=\"MsoHeader\">“Kratom may aid in lessening the symptoms of opioid withdrawal.”\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp class=\"MsoHeader\">On your webpage https:\u002F\u002Fklaritykratom.com\u002Fkratom-for-sale\u002Fstrains\u002F:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli class=\"MsoHeader\">\"Red vein kratom has stronger pain-relieving properties and is used as the best supplement in place of pharmaceutical medicines. It is good for beginners and also for those who are drug addicts. Because it has stronger features that prevent the symptoms of opiate addicts.”\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp class=\"MsoHeader\">On your webpage https:\u002F\u002Fklaritykratom.com\u002Fkratom-for-sale\u002Fstrains\u002Fborneo\u002F:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli class=\"MsoHeader\">“[T]his strain is best for the removal of any opioid effects . . . This strain lessens the effects of other opiates and, most of the time, removes the habit of other opiates too.”\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp class=\"MsoHeader\">From a review on your webpage https:\u002F\u002Fklaritykratom.com\u002Fbuy-kratom\u002Fklarity-kratom-maengda-powder-200-grams\u002F:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli class=\"MsoHeader\">“Its [sic] been great to give up the opioids and feel good.”\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp class=\"MsoHeader\">Your kratom products are not generally recognized as safe and effective for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 355(a). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. There are no FDA-approved applications in effect for the above-mentioned products.\u003C\u002Fp>\n\n\u003Cp class=\"MsoHeader\">This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA and FTC laws and regulations.\u003C\u002Fp>\n\n\u003Cp class=\"MsoHeader\">This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.\u003C\u002Fp>\n\n\u003Cp class=\"MsoHeader\">Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.\u003C\u002Fp>\n\n\u003Cp class=\"MsoHeader\">Your response should be sent to U.S. Food and Drug Administration, CDER\u002FOC\u002FOffice of Unapproved Drugs and Labeling Compliance, by email to \u003Cstrong>FDAADVISORY@fda.hhs.gov\u003C\u002Fstrong>.\u003C\u002Fp>\n\n\u003Cp class=\"MsoHeader\">\u003Cstrong>FTC Cease and Desist Demand:\u003C\u002Fstrong> In addition, it is unlawful under the FTC Act, 15 U.S.C. §§ 41–57, to advertise that a product can prevent, treat, or cure human disease, including addiction to alcohol, nicotine, or drugs, unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. For addiction, no such study is currently known to exist for kratom. Thus, any addiction treatment claims regarding such products are not supported by competent and reliable scientific evidence. \u003Cstrong>You must immediately cease making all such claims\u003C\u002Fstrong> and staff strongly suggests that you review all health-related claims that you or any of your affiliates are making in any medium to ensure that they are properly substantiated and do not violate the FTC Act. \u003Cstrong>Violations of the FTC Act may result in legal action seeking a Federal District Court injunction. In addition, pursuant to Section 8023 of the Opioid Addiction Recovery Fraud Prevention Act of 2018, 15 U.S.C. § 45d, marketers who make deceptive claims about the treatment, cure, prevention, or mitigation of any substance use disorder, including addiction to alcohol, nicotine, or drugs, are subject to a civil penalty of up to $46,517 per violation and may be required to pay refunds to consumers or provide other relief pursuant to Section 19(b) of the FTC Act, 15 U.S.C. § 57b(b).\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp class=\"MsoHeader\">With regard to the advertising claims discussed above, within fifteen (15) working days of receipt of this letter, please notify Rick Quaresima, Assistant Director of the FTC’s Division of Advertising Practices, via electronic mail at rquaresima@ftc.gov of the specific actions you have taken to address FTC's concerns. If you have any questions regarding compliance with the FTC Act, please contact Mr. Quaresima at (202) 326-3130.\u003C\u002Fp>\n\n\u003Cp class=\"MsoHeader\">Sincerely,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp class=\"MsoHeader\">Donald D. Ashley\u003Cbr>\nDirector\u003Cbr>\nOffice of Compliance\u003Cbr>\nCenter for Drug Evaluation and Research\u003Cbr>\nFood and Drug Administration\u003C\u002Fp>\n\n\u003Cp class=\"MsoHeader\">Sincerely,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp class=\"MsoHeader\">Serena Viswanathan\u003Cbr>\nAssociate Director\u003Cbr>\nDivision of Advertising Practices\u003Cbr>\nFederal Trade Commission\u003C\u002Fp>\n\n\u003Cp class=\"MsoHeader\">_______________________\u003C\u002Fp>\n\n\u003Cp class=\"MsoHeader\">\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued October 26, 2017, and subsequently renewed), available at \u003Ca href=\"https:\u002F\u002Fwww.phe.gov\u002Femergency\u002Fnews\u002Fhealthactions\u002Fphe\u002FPages\u002Fdefault.aspx\">https:\u002F\u002Fwww.phe.gov\u002Femergency\u002Fnews\u002Fhealthactions\u002Fphe\u002FPages\u002Fdefault.aspx\u003C\u002Fa>.\u003C\u002Fp>\n\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVia Email\n\nProduct:\n\nDrugs\n\nRecipient:\n\nKlarity Kratom\n\n2641 S. Hill St.\n\nLos Angeles, CA 90007\n\nUnited States\n\nklaritykratom@gmail.com\n\nklaritykratom3@gmail.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research | CDER\n\nUnited States\n\nFederal Trade Commission\n\nWARNING LETTER\n\nJune 30, 2022\n\nRE: 634501\n\nDear Klarity Kratom:\n\nThis letter is to advise you that the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) reviewed your website at https:\u002F\u002Fklaritykratom.com\u002F on May 31, 2022 and in June 2022, respectively, and have determined that you take orders there for numerous kratom products. The claims on your website establish that your kratom products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act.\n\nThe Department of Health and Human Services (HHS) has determined that a public health emergency exists nationwide involving the opioid crisis.1 You market kratom products for the treatment or cure of opioid addiction and withdrawal symptoms. However, these products have not been determined by FDA to be safe and effective for these (or any other) uses. Further, the unproven treatments could cause patients to forego or delay FDA-approved treatments for opioid addiction or withdrawal. The marketing and sale of unapproved opioid addiction treatment products is a potentially significant threat to the public health. Therefore, FDA is taking measures to protect consumers from products that, without approval by FDA, claim to diagnose, mitigate, prevent, treat or cure opioid addiction.\n\nUnapproved New Drugs\n\nYour kratom products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and\u002For intended to affect the structure or any function of the body.\n\nExamples of claims observed on your website, https:\u002F\u002Fklaritykratom.com\u002F, that establish the intended use of your products as drugs include, but may not be limited to, the following:\n\nOn your webpage https:\u002F\u002Fklaritykratom.com\u002F2018\u002F09\u002F20\u002Fkratom-an-introduction\u002F:\n\n“[O]ver ninety percent of patients suffering from rheumatoid arthritis . . . have reported partial or total improvement in their symptoms after using Kratom.”\n\n“Kratom may aid in lessening the symptoms of opioid withdrawal.”\n\nOn your webpage https:\u002F\u002Fklaritykratom.com\u002Fkratom-for-sale\u002Fstrains\u002F:\n\n\"Red vein kratom has stronger pain-relieving properties and is used as the best supplement in place of pharmaceutical medicines. It is good for beginners and also for those who are drug addicts. Because it has stronger features that prevent the symptoms of opiate addicts.”\n\nOn your webpage https:\u002F\u002Fklaritykratom.com\u002Fkratom-for-sale\u002Fstrains\u002Fborneo\u002F:\n\n“[T]his strain is best for the removal of any opioid effects . . . This strain lessens the effects of other opiates and, most of the time, removes the habit of other opiates too.”\n\nFrom a review on your webpage https:\u002F\u002Fklaritykratom.com\u002Fbuy-kratom\u002Fklarity-kratom-maengda-powder-200-grams\u002F:\n\n“Its [sic] been great to give up the opioids and feel good.”\n\nYour kratom products are not generally recognized as safe and effective for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 355(a). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. There are no FDA-approved applications in effect for the above-mentioned products.\n\nThis letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA and FTC laws and regulations.\n\nThis letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.\n\nPlease notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.\n\nYour response should be sent to U.S. Food and Drug Administration, CDER\u002FOC\u002FOffice of Unapproved Drugs and Labeling Compliance, by email to FDAADVISORY@fda.hhs.gov.\n\nFTC Cease and Desist Demand: In addition, it is unlawful under the FTC Act, 15 U.S.C. §§ 41–57, to advertise that a product can prevent, treat, or cure human disease, including addiction to alcohol, nicotine, or drugs, unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. For addiction, no such study is currently known to exist for kratom. Thus, any addiction treatment claims regarding such products are not supported by competent and reliable scientific evidence. You must immediately cease making all such claims and staff strongly suggests that you review all health-related claims that you or any of your affiliates are making in any medium to ensure that they are properly substantiated and do not violate the FTC Act. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction. In addition, pursuant to Section 8023 of the Opioid Addiction Recovery Fraud Prevention Act of 2018, 15 U.S.C. § 45d, marketers who make deceptive claims about the treatment, cure, prevention, or mitigation of any substance use disorder, including addiction to alcohol, nicotine, or drugs, are subject to a civil penalty of up to $46,517 per violation and may be required to pay refunds to consumers or provide other relief pursuant to Section 19(b) of the FTC Act, 15 U.S.C. § 57b(b).\n\nWith regard to the advertising claims discussed above, within fifteen (15) working days of receipt of this letter, please notify Rick Quaresima, Assistant Director of the FTC’s Division of Advertising Practices, via electronic mail at rquaresima@ftc.gov of the specific actions you have taken to address FTC's concerns. If you have any questions regarding compliance with the FTC Act, please contact Mr. Quaresima at (202) 326-3130.\n\nSincerely,\n\n\u002FS\u002F\n\nDonald D. Ashley\n\nDirector\n\nOffice of Compliance\n\nCenter for Drug Evaluation and Research\n\nFood and Drug Administration\n\nSincerely,\n\n\u002FS\u002F\n\nSerena Viswanathan\n\nAssociate Director\n\nDivision of Advertising Practices\n\nFederal Trade Commission\n\n_______________________\n\n1 Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued October 26, 2017, and subsequently renewed), available at https:\u002F\u002Fwww.phe.gov\u002Femergency\u002Fnews\u002Fhealthactions\u002Fphe\u002FPages\u002Fdefault.aspx.","2026-08-20T01:47:39.679+00:00",[22,23,24,9,25,26,26,26],"\u003Ctime datetime=\"2022-07-05T13:20:00Z\">07\u002F05\u002F2022\u003C\u002Ftime>\n","\u003Ctime datetime=\"2022-06-30T04:00:00Z\">06\u002F30\u002F2022\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fklarity-kratom-634501-06302022\">Klarity Kratom\u003C\u002Fa>","Finished Pharmaceuticals\u002FUnapproved New Drug\u003Cbr \u002F>\r\n","","2026-08-18T06:42:29.262718+00:00","2026-08-20T02:24:56.48659+00:00",{"510k":30,"classification":31,"enforcement":32,"event":33,"pma":34,"warning_letter":35},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]